Nicotine Replacement Therapy (NRT) products are devices and compositions typically including strategically-dosed delivery forms of nicotine. The products are designed to aid the user in cessation of tobacco addiction. Many nicotine replacement therapy products include concentrations of nicotine designed to reduce the desire for tobacco products. Smoking cessation programs use these therapies to replace the physiologic need for nicotine from tobacco products while using other modalities to reduce the psychological desire to use tobacco products. The uses of NRT products vary from smoking cessation devices and compositions, to recreational compositions to enhance the user's recreational experience, or minimize socially-unwanted or illegal activities now associated with the smoking of tobacco in public.
The nicotine currently used in NRT products is typically tobacco-derived, i.e., extracted from tobacco leaves. The nicotine extract is isolated in its semi-pure form along with many contaminants. For example, a typical USP grade nicotine derived from tobacco often contains at least the following contaminants: Anabasine; Cotinine; Nornicotine; and Trans-3′-hydroxycotinine; as well as the known carcinogen, polyaromatic hydrocarbons. Many of these tobacco-derived nicotine contaminants have been shown to cause serious ailments for the human system, including cancer. Tobacco-derived nicotine, even when purified to levels compliant with the USP monograph for purity, retains many of these contaminants, and thus even highly-purified tobacco-derived nicotine can be problematic for the consumer. In addition, these contaminates contribute to a less-desirable consumer product, primarily due to foul taste and a malodorous characteristic of the products utilizing commercially available tobacco-derived nicotine extracts. These aspects of the tobacco-derived nicotine severely hamper the quality of NRT oral products such as sprays, strips, snuffs, chews, or gums. The contaminants, although sometimes in low concentrations, do get into the human system upon using traditional NRT products.